1303346
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 13, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Ormond Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23038 | ISO 13485:2016 Clause 4.2.4 | Lack of document control |
| 23179 | ISO 13485:2016 Clause 7.5.8 | Product not identified by suitable means |